MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VANCI SI SURGICAL SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Model Number IS3000 A60P9B

Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

Isi received the units involved with this complaint, however, the failure analysis investigation is still in progress and therefore the root cause of the customer reported failure has not been determined.A follow up mdr will be submitted once the failure analysis has been completed and/or additional information is received.This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if this malfunction were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vanci-assisted total benign hysterectomy procedure, the customer experienced a black image in the right eye.The customer performed an emergency power off (epo) on the surgeon side console (ssc) and reseated the blue fiber cable.The system would power up normally but there was no image output in the right eye of the ssc.There was no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) contacted the initial reporter and obtained the following additional information: it was confirmed that the surgeon successfully completed the procedure without patient harm using only one eye.An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure.The fse replaced the personality module surgeon console (pmsc) and the high resolution stereo viewer (hrsv).The pmsc is a module that consists of 5 interface boards.The fse replaced the pmsc and the hrsv to repair the system.The hrsv provides the video image for the ssc.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the units involved with this complaint and completed the device evaluations.Failure analysis investigations are as follows: the reported failure could not be reproduced on the pmsc.The board was installed into pca test system and a video test was ran along with 10 power cycles and sitting idle for one hour.Failure analysis repaired the power video on the monitor hrsv.The ic caps were replaced.All functions were tested and a backlight calibration was performed.This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.

• Brand Name: DA VANCI SI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 6673328
• MDR Text Key: 78596518
• Report Number: 2955842-2017-00400
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS3000 A60P9B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1